Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton
FDA Recall Z-1235-2007 · Posted 2007-09-20
Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeNGT
Date Initiated2007-07-30
Date Terminated2008-04-01
Product Quantity33,240 units
Reason for Recall
Particulate matter in product.
Firm Action
The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.
Root Cause
Other
Distribution Pattern
The products were shipped to distributors nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.